Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

BEVYXXA (NDA-208383)

(BETRIXABAN)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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08/24/2020 (SUPPL-7)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.5 Increased Risk of Thrombosis in Patients with Triple Positive Antiphospholipid Syndrome

(Newly added section)

Direct-acting oral anticoagulants (DOACs), including BEVYXXA, are not recommended for use in patients with triple-positive antiphospholipid syndrome (APS). For patients with APS (especially those who are triple positive [positive for lupus anticoagulant, anticardiolipin, and anti–beta 2- glycoprotein I antibodies]), treatment with DOACs has been associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy.

6 Adverse Reactions

(Newly added information)

Increased Risk of Thrombosis in Patients with Triple Positive Antiphospholipid Syndrome [see Warnings and Precautions (5.5)].

07/18/2019 (SUPPL-6)

Approved Drug Label (PDF)

7 Drug Interactions

7.2 Inducers of P-gp

(new subsection added)

Co-administration of BEVYXXA with P-gp inducers (e.g., carbamazepine, phenytoin, rifampin, St. John's wort) may result in a decrease in systemic exposure of betrixaban and its pharmacodynamic effects. Therefore, avoid the use of BEVYXXA in patients receiving P-gp inducers.

8 Use in Specific Populations

8.7 Hepatic Impairment

(subsection revised, additions underlined)

In a pharmacokinetic study, compared to subjects with normal hepatic function, AUC increases of 30% were observed in subjects with mild hepatic impairment. No dose adjustment is required in patients with mild hepatic impairment.

Compared to subjects with normal hepatic function, AUC increases of 57% were observed in subjects with moderate hepatic impairment. The safety or PK of BEVYXXA in patients with severe hepatic impairment was not evaluated. Avoid the use of BEVYXXA in patients with moderate and severe hepatic impairment or with any hepatic disease associated with coagulopathy.